“Digital Pathology in Diagnostics” guideline: Reporting on digital images

Abstract

Background: The digitization of medicine is gaining momentum in pathology. Long-known technologies have reached such a degree of maturity that their use in primary diagnostics in routine pathology will be possible. In spite of the complexity of technological solutions and the far-reaching consequences in terms of diagnostic reliability, as well as due to the high investments, the decision for a specific product may become highly sophisticated for a pathologist. Aim: An implementation guide for Digital Diagnostics in Pathology is presented to describe technical and legal conditions for making this new technology feasible for the single pathologist. Results and discussion: For more than two years, the Digital Pathology Commission of the Federal Association of German Pathologists developed and discussed this implementation guide for digital diagnostics, especially for the use of virtual microscopy in the daily pathology routine in Germany. The key is the principal comparability of diagnostic reliability between conventional stained microscopic slides and their digital images, which have to be shown by the potential user. In eight chapters, the validation procedure as well as technical minimum requirements in slide scanners, the visualization pipeline, archiving, and integration in the pathology workflow are described.